Sr. Business Systems Analyst - Validation; CSA) Governance & Process

Sr. Business Systems Analyst
- Validation (CSA) Governance & Process Support

Title: Sr. Business Systems Analyst
- Validation (CSA) Governance & Process Support

Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively seeking a Sr. Business Systems Analyst – Validation (CSA) Governance & Process Support to join the IT team responsible for supporting Quality Systems, Regulatory Affairs, Product Development, and Research business teams. The IT Quality team governs and provides guidance for a variety of IT processes supporting the Arthrex Quality Management System (QMS), including Non-Product Software Validation (inclusive of both traditional programmatic software, and AI/Machine Learning models, functions, and features), IT Change Management, and other processes supporting validation and the software development lifecycle.

Excellent communication, analytical, and technical project management skills are essential. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

* We would like for this position to sit with us at our Naples Florida Global Headquarters but we can be flexible on location for the right candidate.

Main Objective:

Responsible for facilitating process improvements engaging business and IT, as well as design and/or configure, analyze, implement, test, and maintain the organization’s on-premise and cloud computing applications.

Essential Duties and Responsibilities:

• Obtain a deep understanding of relevant business area(s) and business processes to be able to recommend solutions and build high-quality requirements.
• Shape business requirements by making recommendations and suggesting alternatives to proposed solutions.
• Participate in Application Analysis, Configuration, Testing, Management, and Maintenance in an Enterprise environment, including (where applicable):
  • Access administration and user onboarding.
  • Issue resolution, patching, and performance monitoring.
  • Reliability, backup, disaster recovery, and business continuity.
  • Monitor system logs for unusual activity and escalation or makes recommendations for resolution.
  • Participate in infrastructure projects to provide application specifications and requirements, as well as operational, run book, and capacity planning information.
• Support user acceptance testing and user training activities.
• Adhere to the Quality System Procedures and Change Control.
• Lead and/or participate in delivery of projects.
• Provide Application End User support.
• Respond, resolve, or escalated reported incidents.
• Under management direction, may participate as SME for audits.
• Responsible for coordinating application needs from back-end platforms through user interface.
• Ensure stability, integration, and integrity of production systems.
• Complete all QA Non-Conformance and Corrective Actions in a timely manner.
• Participate in assessment of application security and identity management requirements, where applicable.
• Create artifacts as appropriate, including business case documentation, scope documentation, detailed functional requirements, operational requirements, process flows, and manual and automated test cases.
• Understand technical options, limitations, costs, and risks.
• Communicate tradeoffs to business partners and work with them to shape requirements accordingly.
• Help resolve competing priorities between stakeholder groups by facilitating stakeholder discussions and escalation issues where appropriate.

Education and Experience:

• Bachelor’s degree or equivalent required.
• 5+ years of Business Systems Analyst or related experience required.
• Experience supporting validation, specifically software/system (CSA) processes preferred.
• Experience with reporting and analytics tools such as Power BI preferred.

Additional

Duties and Responsibilities:

• Author and maintain Work Instructions, related process documentation, and technical documentation.
• Provide guidance and clarify process requirements for users planning and executing non-product-software validation processes.
• Facilitate training sessions where audiences arrive with differing levels of exposure and…